Spécialiste, Affaires Réglementaires (contrat De 12 Mois) | Specialist, Regulatory Affairs (12-month Contract)

Organon LLC

Canada
Health canada regulations knowledge
Regulatory submissions preparation
Interaction with health canada
The Specialist is responsible for executing activities related to regulatory affairs, reporting to the Associate Director, Regulatory Affairs

Job Summary

  • The Specialist is responsible for executing activities related to regulatory affairs, reporting to the Associate Director, Regulatory Affairs.
  • Key responsibilities include preparing federal regulatory submissions, interacting with Health Canada, and supporting the maintenance of Establishment Licenses.
  • The incumbent will complete tasks in a manner fully consistent with the company’s commitment to its values, standards, policies, procedures, industry standards, and all applicable laws and regulations.

Matching Summary

The Specialist is responsible for executing activities related to regulatory affairs, reporting to the Associate Director, Regulatory Affairs.

Skills & Requirements

Must-have

  • Health Canada regulations knowledge
  • Regulatory submissions preparation
  • Interaction with Health Canada
  • Archival of regulatory data

Nice-to-have

  • Collaboration and partnering skills
  • Attention to detail and quality
  • DESS or M. Sc. in Drug Development/Regulatory Affairs

Key Requirements

  • Health or life science university degree
  • Prior industry experience in regulatory affairs
  • English and French communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter